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Intervention for

Renal Artery Stenosis

CardioVascular Research Foundation


Renal Artery Stenosis

Incidence

General population 0.1%

Hypertensive population 4.0%

HTN & suspected CAD 10 - 20%

Malignant HTN 20 - 30%

Malignant HTN & renal insufficiency 30 - 40%

HTN and PAD 44%

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Incidence of Unsuspected RAS

196 consecutive patients referred for coronary

angiography for suspected CAD underwent

(drive-by) renal angiography.

90

80

70

60

50

%

40

30

20

10

0

78%

All Patients

33%

18%

CAD RAS RAS > 50%

22% (1 in 5) of the

patients with CAD had

significant (> 50%) renal

artery stenosis.

Jean WJ, et al: Cathet Cardiovasc Diagn 1994;32:8-10.

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Atherosclerotic Renal Artery

Stenosis

Incidence of RAS in Patients with Peripheral Vascular Disease

60

50

40

30

20

Incidence 22 to 59%

39

37

22

59

49

45

10

0

Dustan Olin Wilms Choudri Swartbol Missouris

Scoble JE. In Renal Vascular Disease 1996:143-9

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The Consequences:

Renovascular Hypertension

• Cardiovascular

• Renal

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Cardiovascular Consequences

• LVH

• Unstable angina

• Pulmonary congestion

• Myocardial infarction

• Aortic dissection

• Stroke

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4-Year Mortality

Mulivariate Analysis

100

90

Variable

Risk Ratio

P value

Survival

80

70

60

P = 0.0001

No RAS

RAS

RAS

LVEF

CRI

2.9 (1.7 - 7.0)

1.7 (1.2 - 2.2)

1.3 (1.1 - 1.5)

0.0001

0.0002

0.02

50

0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0

CHF

2.4 (1.3 - 4.1)

0.0021

N = 1047

N = 188

Years

496

50

Conlon PJ, et al: J Am Soc Nephrol 1998;9:252-56.

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Natural History of RAS

• Trend in untreated or medically treated

renal artery stenoses for progression of

stenosis (to occlusion) and loss of renal

function.

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Natural History of

Renal Artery Stenosis

Reference F/U,

Months

Patients Progression,

N (%)

Total

Occlusion

Wollenweber, 12-88 30 21 (70) NA

1968

Meaney, 6-120 39 14 (36) 3 (8)

1968

Dean, 1981 6-102 35 10 (29) 4 (11)

Schreiber, 12-60+ 85 37 (44) 14 (16)

1984

Tollefson, 15-180 48 34 (71) 7 (15)

1991

TOTAL 237 116 (49) 28 (14)

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Review of 5 angiographic trials.

Ann Intern Med 1993;118:712-9


Progression

24,312

Diagnostic caths

14,152

Abdominal aortogram

1,189

F/U Aortogram

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Suspected abdominal aorta or renal disease

> 6 months between two angiograms

Crowley JJ, et al: Am Heart J 1998;136:913-8.


Progression

RAS progression according to time

between studies (N = 1189)

30

Incidence of RAS

Progression (%)

25

20

15

10

5

14%

30%

0

1 2 3 4 5 6

Years between caths

Crowley JJ, et al: Am Heart J 1998;136:913-8.

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Loss Of Renal Function

Serum Creatinine (µmol/L)

150

100

50

0

Disease progression is associated

with a decline in renal function.

97 ± 44

P = 0.01

141 ± 114

0% > 75 %

Stenosis at Follow-up

Patients with normal renal arteries at baseline.

Crowley JJ, et al: Am Heart J 1998;136:913-8.

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Renal Artery Stenosis

Diagnosis

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Diagnostic Tests

• IVP

• Renal vein renins

• Radionuclide renography

• Renal artery duplex imaging

• Magnetic resonance angiography

• Spiral computed tomography

• Angiography

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Drive-By Angiography

• Renal angiography during cardiac or

peripheral angiography in patients at

increased risk for having asymptomatic

renal artery stenosis:

- Atherosclerosis

- Hypertension

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Routine Screening Angiography

The Facts

• Incidence of RAS is high in

this population.

• Progression (silent) with loss of renal mass.

• Risk of screening angiography is minimal.

• RAS independently impacts prognosis.

• Angiography is the “gold standard” for diagnosis.

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Low Risk Information

• Neglible risks of abdominal Aortography

- Little if any extra contrast.

- Minimal x-ray.

- Pigtail catheter is atraumatic and will be

advanced to the heart anyway.

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Renal Artery Stenting

Effect and Indication

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Goal of Renal Stenting

• Clinical goals

- Improves control of HTN

- Preserves renal function

- Controls of cardiac syndromes

(CHF/Angina)

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Criteria For Renal Stenting

• Which lesions, if any, should be treated ?

- Solitary ≥ 70% stenosis.

- Bilateral ≥ 70% stenoses.

- Unilateral ≥ 70% stenosis.

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RA Stenting - Technical Success

Study Series Year of Study # of Stent Ostial Success Definition Technical

Publication Period Arteries Type Lesion Success (%)

Rodriquez-Lopez 1999 93-96 125 Palmaz 66 No RS/dissection 98

van de Ven 1999 93-97 52 Palmaz 100 RS*


RA Stenting - Restenosis

Study Series # of Arteries Ostial Stent Method of Average Restenosis

Arteries Evaluated Lesion Type Evaluation time to (% of arteries

(% original evaluation evaluated)

total arteries)

(months)

van de Ven, 1999 52 50 (95%) 100 Palmaz angio* 6 21%

Rocha-Singh, 1999 180 158 (88%) 43 Palmaz duplex+angio 13 12%

Tuttle, 1998 148 49 (33%) 100 Palmaz angio 8 14%

Rundback, 1998 54 28 (52%) NA Palmaz angio+spiral CT 12 26%

White, 1997 133 80 (60%) 81 Palmaz angio* 9 19%

Harden, 1997 32 24 (75%) 75 Palmaz angio* 6 12%

Blum, 1997 74 74 (100%) 100 Palmaz angio* 24 11%

Henry, 1996 64 54 (84%) 53 Palmaz angio* 14 9%

Iannone, 1996 83 69 (85%) 78 Palmaz duplex 11 14%

Dorros, 1995 [30] 92 56 (61%) 100 Palmaz angio* 7 25%

Hennequin, 1994 21 20 (95%) 33 Wallstent angio* 29 20%

Rees, 1994 296 150 (51%) 100 Palmaz angio* 7 33%

Weighted Average 10 ~20%

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Renal Stent Patency

6-year follow-up

n = 74

PATENCY

100





50





0

Secondary

Primary

0 12 24 36 48 60

92.4%

84.5%

F/U MONTHS

N = 74 48 29 18 15 7

Blum, et al. N Engl J Med. 1997;336:459-465.

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Renal Artery Stenting &

Renal Dysfunction


Effect of Renal Artery Stenting on

Renal Function and Size

• 25 patients (mean 20±11 m)

• Renal stenting:

- CRI (Cr ≥ 1.5 mg/dL)

- Global renal ischemia (≥

70% stenosis)

- Bilateral RAS

- Unilateral RAS with solitary

kidney

• Before intervention all negative

slope

• After intervention, slopes were

positive in 18 and less negative

in 7 patients

Slope Reciprocal

Serum

Creatinine

Circulation 2000;102:1671-7

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Kidney Size Following Renal Stenting

Kidney size did not change

• Pre-intervention and serial follow-up

sonograms obtained

• Baseline renal length 10.4±1.4 cm

• Follow-up renal length 10.4 ±1.1 cm (mean

follow-up 19 ±10 months

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Circulation 2000;102:1671-7


Effect on Renal Function

Table 4. Effect of Renal Stenting on Renal Function

Study series

No. of patients

Renal function

Improved (%) Stable (%) Deteriorated (%)

van de Ven, 1999 42 12% 62% 26%

Rocha-Singh, 1999 150 22% 70% 8%

Tuttle, 1998 129 15% 81% 4%

Dorros, 1998 163 18% 48% 34%

Rundback, 1998 45 20% 47% 33%

Harden, 1997 32 34% 38% 28%

Weighted Averag 19% 62% 19%

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Lim and Rosenfield, Curr Int Cardiol 2000,2:130-139.


Atherosclerotic Renal Artery Stenosis:

Who Should Be Revascularized?

• Dialysis-dependent renal failure with

> 70% renal artery stenosis to entire

functioning renal mass

- Bilateral RAS

- RAS to solitary functioning kidney

• Rapid decline in renal function in the

14 weeks prior to starting dialysis is favorable

prognostic sign for recovery of renal function

(Hansen, 1995)

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Mortality in ESRD Attributed to RAS

14

Annual Increase %

12

10

8

6

4

2

0

RAS-ESRD DM-ESRD ESRD Total

Am J Kidney Dis 2001;37:1184-90

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Renal Artery Stenosis

and HTN


Renal Artery Stenting

Effect on Hypertension

Study series

No.

Cure

(%)

Improved

(%)

Benefits

(%)

Tegtmeyer

Klinge

Martin

Lossino

Rodriguez-Perez

Blum

Pooled Result

65

134

94

153

37

74

23

10

22

12

0

16

14

71

68

46

51

81

62

63

94

78

68

63

81

78

586 ~ 77%

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• Restenosis rate of 17% after stenting is comparable to restenosis

rates in literature

- Extremely favorable compared to PTRA alone

- Comparable to surgical revascularization

• Blood Pressure Response showed significant reductions in

blood pressure at 9 and 24 months

- Systolic:

• 18.1 point improvement at 9 mo. (10.8% decrease)

• 18.3 point improvement at 24 mo. (10.9% decrease)

- Diastolic:

• 4.2 point improvement at 9 mo. (5.1% decrease)

• 4.7 point improvement at 24 mo. (5.7% decrease)

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ASPIRE 2

AStudy to evaluate the safety and effectiveness of the Palmaz balloon

expandable stent In the REnal artery after failed angioplasty

Rocha-Singh K, J Am Coll Cardiol 2005;46:776-86.


ASPIRE 2

AStudy to evaluate the safety and effectiveness of the Palmaz balloon

expandable stent In the REnal artery after failed angioplasty

ASPIRE 2 Trial

Baseline 208 167.6±25.2

Systolic Pressure

Visit N Mean±SD P-Value

Discharge 202 147.6±22.3


Atherosclerotic Renal Artery Stenosis:

Who Should Be Revascularized?

• Refractory/resistant hypertension and

unilateral/bilateral > 70% RAS

- Expect decrease in number of

antihypertensive medications required

- Easier to control blood pressure

- Unlikely to “cure” hypertension

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CHF and Pulmonary

Edema


Renal Artery Stenting for Control of

Congestive Heart Failure

• 39 RAS for of

recurrent CHF and

flash pulmonary edema

• All patients had either:

- Bilateral

RAS >70% (n =

18) or >70% RAS

to a solitary kidney

(n = 21)

- Of patients with

bilateral RAS, 12

(66.6%) underwent

bilateral stenting

Gray BH, et al. Vascular Med. 2002;7:275-279.

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mmHg

200

180

160

140

120

100

80

60

40

20

0

4

3

NYHA 2

1

0

174

Pre

2.9

Pre

85

p


Effects of Renal Artery Stenting on

Hospitalizations for CHF

100

80

60

40

Pre Stent

Post Stent

20

0

0 1 2 3 4 5 6

Gray BH, et al. Vascular Med. 2002;7:275-279.

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Atherosclerotic Renal Artery Stenosis:

Who Should Be Revascularized?

• Recurrent “flash” pulmonary edema

- Solitary functioning kidney

- Bilateral renal artery stenosis

- Improvement in symptoms; blood

pressure; reduction in hospitalizations for

flash pulmonary edema

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RAS without HTN or RI


Atherosclerotic Renal Artery Stenosis:

Who Should Be Revascularized?

• Unilateral renal artery stenosis with

normal/well-controlled hypertension, normal

renal function

- Observe

• Serial duplex surveillance program

- (?) Revascularize if lesion is critical

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Renal Artery Stenting

Techniques of Renal

Intervention

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Renal Artery Stenting - 1993

Renal Artery Stenting - 2006

8 F Guide

Palmaz

Stent

5F Balloon

0.035”

Guidewire

6 F Guide

Genesis

stent

3.2 F Rx

Balloon

0.014”

Guidewire

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Atheroembolism

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Optimal Technique

Severe atherosclerotic disease of abdominal aorta

• Minimize catheter manipulation in the aorta

Engage renal artery with softer diagnostic

catheter (telescoped inside guide catheter)

“No touch” technique

• Consider brachial artery approach for

heavily diseased abdominal aorta or

extreme downward take-off of renal artery

• Consider embolic protection for high risk

cases with appropriate anatomy

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“No Touch” Technique

1

2

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Optimal Technique

Severe Baseline Renal Insufficiency

• Pretreatment for contrast nephropathy:

- Hydration

- Mucormist

- Sodium Bicarbonate

• Minimize contrast use:

- DSA

- Low or iso-osmolar contrast

- Strict discipline with injections

- Intraarterial Gadolinium or CO 2

- IVUS

• Distal protection?

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Optimal Technique

Ostial Disease

• Identify the true

ostium – angulated

views

• Adequate predilatation

• Leave stent 1-2 mm

into aorta

• Account for stent

shortening

• Confirm complete

ostial coverage

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Improving Results of

Renal Artery Stenting

• Drug Eluting Stents

• Distal Protection Devices


GREAT Trial

Palmaz ® Genesis

TM Peripheral

Stainless Steel Balloon

Expandable Stent: Comparing

a Sirolimus-eluting stent

versus an Uncoated Stent in

REnal

Artery

Treatment

CYPHER Sirolimus-Eluting PALMAZ ®

GENESIS Balloon Expandable Stent

• Multi-center, prospective, non-randomized,

European Feasibility Trial

• Sequential enrollment of 50 bare and 50

sirolimus-eluting stents

• Enrollment complete

• Results will be reported in 2004

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GREAT: Conclusions

• The Sirolimus-eluting Genesis stent results were

encouraging with improved late loss, mean % DS,

and restenosis rate at 6 months compared to the

bare stent

• Restenosis was 14.3% in the BMS and 6.7% in the

Sirolimus-eluting arm

• Sirolimus-eluting stent decreased TVR 50% from

7.7% to 3.8%

• Clinical trials are needed with more patients to

investigate the effect of DES on outcomes

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Distal Protection During Renal Stenting

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Distal Protection

N = 27, 32 procedures

• 24 (92%) patients had renal insufficiency

• Technical success : 100%

• Mean pre-& post-intervention Cr : 1.9 vs 1.6 mg/dL (p


Distal Protection

C Cooper

• Distal protection has a powerful effect on adverse

events during SVG intervention

- preliminary data suggest that distal protection may

prevent renal insufficiency after renal intervention

- However, anatomy may limit utility in renal application

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Edward MS, et al: J Vasc Surg 2006;44:128-35.


Conclusions

• With modern equipment and skilled

operators, renal artery stenting can be

performed with high technical success

(>98%) and low restenosis (15-20%)

• Following successful renal stenting there

is slowing of deterioration of renal

function and prevention of renal atrophy

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Conclusions

• HTN is rarely cured (50%) will have some

benefit with regards to HTN control

and/or decreased anti-hypertensive meds

following renal stenting

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Conclusions

• Preliminary results showed favorable

outcomes for use of DES or protection

devices, but more larger data is

required to use them routinely in renal

artery stenting

CardioVascular Research Foundation

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